MAUDE Adverse Event Report: OWEN MUMFORD LIMITED UNIFINE PENTIPS PLUS; PEN NEEDLE

Model Number	4938494
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient called in on (b)(6) 2022 to report that a pen needle got stuck in her leg, but that she was able to remove it herself.She also complained that another needle was already bent and was not able to give herself an injection with it.
Additional Manufacturer Narrative
A batch file and retained sample review was performed and did not highlight any anomalies that could account for this event.The devices in question were returned for examination and upon inspection by mps team at owen mumford ltd, one pentip hub had the needle bent back and one pentip hub had the needle snapped off.The samples were then placed under high magnification for further assessment.The needle tube inside the hub, has been bent at an angle and squashed which indicates material resistance from force.From the findings observed in figure 1, the needle appears to have been broken off under force after moulding, indicating no issues with the assembly / manufacture of the device.Figure 2 shows the needle bent away from its original vertical positioning.It also has a second bend towards the tiip of the needle indicating a use of force upon the needle causing it to bend.This damage to the needle indicates the needle has been used.The needle shield could not have been placed over the needle if the needle was damaged.This could be caused by placing the hub at an angle when inserting the needle into the disposal chamber.The needle is also discolored which indicates that insulin has oxidized on the needle, which also indicates the pentip was used.

• Brand Name: UNIFINE PENTIPS PLUS
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): OWEN MUMFORD LIMITED; brook hill; woodstock, oxfordshire OX20 1TU; UK OX20 1TU
• MDR Report Key: 16253104
• Report Number: 1058602-2023-00001
• Device Sequence Number: 12080615
• Product Code: FMI
• UDI-Device Identifier: 00096295125597
• UDI-Public: 00096295125597
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2023
• Report Date (Section F): 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 4938494
• Device Catalogue Number: 4938494
• Device Lot Number: 22EA004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/21/2022
• Event Location: Home
• Date Report to Manufacturer: 12/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Date Report Sent to FDA: 01/26/2023